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# IRB Written Procedures Guidance Out
- URL: https://www.fdaweb.com/irb-written-procedures-guidance-out/
- Published: 2016-08-02T12:00:00.000Z
- Updated: 2026-09-14T21:20:26.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5136371

FDA and the HHS Office for Human Research Protections have issued a joint guidance to assist institutional review board (IRB) administrators, chairs, and other officials responsible for preparing and maintaining written procedures for the IRB. The [guidance](http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM512761.pdf?ref=fdaweb.com) provides an IRB written procedures checklist incorporating the HHS and FDA regulatory requirements for IRB written procedures and additional topics that the agencies recommend including in written procedures. When finalized, the document will supersede an FDA 1998 document and an HHS 2011 guidance.